Implant Based Breast Reconstruction Using a Titanium-Coated Polypropylene Mesh (TiLOOP® Bra): A Systematic Review and Meta-analysis.

BACKGROUND: Implant-based breast reconstruction (IBBR) can be performed using a variety of biological and synthetic meshes. However, there has yet to be a consensus on the optimal mesh. This study investigates the safety and patient satisfaction of using TiLOOP® Bra in IBBR and compares its postoperative complication risk with that of porcine acellular dermal matrix (ADM) and SERAGYN® BR. METHODS: The literature review was performed via PRISMA criteria, 23 studies met the inclusion criteria for the TiLOOP® Bra review, and 5 studies met the inclusion criteria for the meta-analysis. Patient characteristics and per-breast complications were collected. Data were analyzed using Cochrane RevMan and IBM SPSS. RESULTS: In 3175 breasts of 2685 patients that underwent IBBR using TiLOOP® Bra, rippling was observed as the most common complication, followed by seroma and capsular contracture. No significant difference in the overall complication rate between pre- and sub-pectoral IBBR using TiLOOP® Bra. However, the meta-analysis showed that the TiLOOP® Bra group had significantly lower odds of implant loss, seroma, wound dehiscence, and the need for reoperation or hospitalization than the ADM group. Additionally, the TiLOOP® Bra group had a significantly lower seroma rate compared to the SERAGYN® BR group, while the other outcome indicators were similar between the two groups. CONCLUSION: TiLOOP® Bra has become increasingly popular in IBBR in recent years. This review and meta-analysis support the favorable safety profile of TiLOOP® Bra reported in the current literature. The meta-analysis revealed that TiLOOP® Bra has better safety than ADM and a comparable risk of complications compared to SERAGYN® BR. However, as most studies had low levels of evidence, further investigations are necessary. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The TiLOOP® Male Sling: Did We Forejudge.

INTRODUCTION: To evaluate the safety and efficacy of the TiLOOP® male sling (pfm medical, Cologne, Germany) used in the treatment for male stress urinary incontinence (SUI). MATERIAL AND METHODS: We retrospectively evaluated a total of 34 patients with a TiLOOP® male sling. Perioperative complication rates were assessed and validated questionnaires were prospectively evaluated to assess quality of life and satisfaction rate. Outcome and complication rates were analysed by using descriptive statistics. Correlation of continence outcome and risk factors was performed with the chi-square test. A p value below 0.05 was considered statistically significant. RESULTS: The majority of patients (70.6%) were diagnosed with mild or moderate male SUI. During surgery, one instance (2.9%) of intraoperative urethral injury was observed. There were no immediate postoperative complications. The mean follow-up time was 44.6 months. An improvement of male SUI was reported by 61.9% of the patients and 38.1% reported no change according the Patient Global Impression of Improvement. The mean perineal pain score was 0.5 according to the international index of pain. CONCLUSIONS: The TiLOOP® is a safe treatment option for male SUI in our cohort with a low complication rate. However, the functional outcome of the TiLOOP® was inferior when compared to the outcome of the AdVance® male sling.

Management of Implant Exposure in One-Stage Breast Reconstruction Using Titanium-Coated Polypropylene Mesh: Sub-Mammary Intercostal Perforator Flap.

INTRODUCTION: One-stage implant-based breast reconstruction using titanium-coated polypropylene mesh is a novel approach widely used in Europe. Complication rates in breast reconstruction with the use of titanium-coated meshes seem to be comparable to those in patients with implant-based breast reconstruction alone. However, the use of synthetic meshes in implant-based breast reconstructive surgery leads to new clinical scenarios with the need for the breast surgeon to face new complications. We present an innovative treatment of implant exposure in the absence of infection in patients who underwent nipple-sparing mastectomy and immediate breast reconstruction with silicone implants and titanium-coated polypropylene mesh by using a pedicled sub-mammary intercostal perforator flap. CASES PRESENTATION: Four patients who experienced implant exposure without infection have been treated with the use of a sub-mammary intercostal perforator flap. Whole coverage of the exposed implant/mesh with a sub-mammary intercostal perforator flap was obtained in all cases. No post-operative complications have been observed, whereas a pleasant aesthetic result has been achieved. Patients' post-operative quality of life and satisfaction levels were measured by the European Organisation for Research and Treatment of Cancer breast cancer-specific quality of life QLQ-BR23 questionnaire and showed an average good satisfaction with the post-operative outcomes (mean QLQ-BR23 score 1.9). DISCUSSION: For the first time, a sub-mammary intercostal perforator flap has been used with the aim of treating implant exposures without removing the prosthesis even in the presence of synthetic meshes, when wound infection was excluded. Although tested on a small series, the sub-mammary intercostal perforator flap might represent a simple, versatile and cost-effective procedure for the management of implant exposure following nipple-sparing mastectomy and immediate reconstruction with silicone implants and synthetic meshes. It should be considered to avoid implant removal followed by delayed free flap reconstruction as "salvage surgery." LEVEL OF EVIDENCE V: This journal requires that the authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Breast reconstruction with TiLOOP® Bra: Another arrow in plastic surgeons' quiver?

BACKGROUND: The use of lower-pole sling products has made immediate breast reconstruction a feasible option in women undergoing skin-nipple sparing and skin-reducing mastectomies. To date, available data on the comparative efficacy of biological and synthetic meshes regarding postoperative complications are scattered and limited. METHODS: A systematic literature search was performed to screen three different databases (PubMed, Web of Sciences, and Embase) using the following keywords: "breast reconstruction" AND "TiLOOP®" OR "Titanium-Coated Polypropylene Mesh" OR "TCPM". The perioperative and demographic characteristics of patients, complications profiles, and patient-reported outcomes were considered. RESULTS: We initially identified 234 articles, of which only 41, including 3923 patients and 5042 reconstructed breasts, fully satisfied the inclusion criteria. CONCLUSION: TiLOOP® Bra could be considered a safe and aesthetically valid alternative to Acellular Dermal Matrices (ADMs) in non-smokers patients undergoing skin-nipple sparing and skin-reducing mastectomies and immediate reconstruction. In such populations, complications are more likely to develop in patients with extreme body mass index values. The incidence of seroma with TiLOOP® Bra is comparable to that of ADMs as it is the beneficial effect in radiated patients, where TiLOOP® Bra seems superior to implant alone reconstruction. It has a good bio-integration with host tissues and resistance to infections in patients with a weakened immune system as a consequence of oncologic perioperative treatments.

Prepectoral implant-based breast reconstruction with TiLOOP® Bra Pocket - a single-centre retrospective study.

BACKGROUND: Prepectoral implant-based reconstruction using synthetic meshes is feasible with good outcomes. We present our data using TiLOOP® Bra Pocket, a novel ready-to-use mesh pocket which acts as an internal bra and prevents the implant from dislocating or twisting. MATERIALS AND METHODS: A single-centre retrospective cohort study was performed to assess short-term complication rates and cosmetic outcomes in patients with prepectoral implant-based reconstruction using the TiLOOP® Bra Pocket. The primary endpoint was complication rates during the first 6 months. The secondary endpoint was the cosmetic outcome after 6 to 12 months, which was judged by two breast surgeons using the Harvard score. RESULTS: A total of 63 breasts (43 patients) were reconstructed using the TiLOOP® Bra Pocket between 2018 and 2020, 57 were immediate reconstructions. The overall complication rate was 30,2% (n = 19/63). Major complications occurred in seven breasts (n = 7/63; 11,1%) and minor complications occurred in 12 breasts (12/63; 19,0%). The unplanned revision rate was 12,7%. The cosmetic outcome was good (Harvard score: mean 3, range 1-4; SD 0,75). Seventeen cosmetic complications were observed (17/63; 27,0%) and six cosmetic revision surgeries were performed (6/63; 9,5%). CONCLUSION: The use of the TiLOOP® Bra Pocket is convenient and standardized because the pocket is preformed and does not require to be sewn first. Cosmetic outcome is good; however, the surgical morbidity needs to be addressed in future reconstructions. Careful patient selection and preparation techniques are vital in order to achieve acceptable complication rates and satisfying cosmetic results.

Immediate prepectoral implant reconstruction using TiLOOP Bra Pocket results in improved patient satisfaction over dual plane reconstruction.

BACKGROUND: Implant-based reconstruction accounts for the majority of breast reconstructive procedures performed in Australia. More recently, immediate prepectoral implant reconstruction using the TiLOOP Bra Pocket has gained popularity. This study compares post-surgical complications and patient-reported quality of life outcomes between immediate prepectoral and dual plane implant reconstruction. METHODS: A retrospective study of 80 consecutive patients who underwent nipple-sparing mastectomies and immediate implant reconstruction was conducted. Implants were either completely covered with TiLOOP Bra and/or TiLOOP Bra Pocket (pfm medical, Cologne, Germany) and secured in the prepectoral space (prepectoral group) or placed in the subpectoral plane with inferolateral mesh coverage (dual plane group). Data surrounding patient demographics, clinical details and post-surgical outcomes were compared. Patient-related quality of life outcomes were assessed with the Breast-Q questionnaire. RESULTS: A total of 80 patients (109 breasts) operated on between June 2016 and December 2018 were included. The prepectoral and dual plane groups comprised of 40 patients each, including 50 and 59 operated breasts, respectively. Post-operative complications were comparable with 11 (22%) overall complications in the prepectoral group and eight (14%) in the dual plane group (P = 0.313). Implant loss was uncommon with four (8%) cases in the prepectoral group and five (8.5%) in the dual plane group (P = 0.929). Patient-reported quality of life outcomes were superior after prepectoral reconstruction with patients reporting a significantly higher score in the satisfaction with breasts domain (68.9 versus 57.5; P = 0.036). CONCLUSION: Immediate prepectoral implant reconstruction with the TiLOOP Bra Pocket was associated with improved patient satisfaction and demonstrated no difference in early post-operative outcomes.

Patient Quality of Life After Subpectoral Implant-based Breast Reconstruction With Synthetic or Biological Materials.

AIM: Quality of life and patient satisfaction after subpectoral breast reconstruction with meshes or acellular dermal matrices (ADM) and implants were assessed using the BreastQ questionnaire to investigate a potential influence of the materials on these parameters. PATIENTS AND METHODS: The BreastQ questionnaire was completed by 121 patients, who had received material-assisted, heterologous, subpectoral breast reconstruction between 2010 and 2018. RESULTS: Answers were similar independent of the reconstruction materials used. After prophylactic mastectomy, the physical wellbeing (chest) improved significantly with all materials (p=0.04). Postoperative radiotherapy significantly reduced satisfaction with outcome (p=0.005). Patients under 50 years old had significantly better postoperative sexual wellbeing than older patients (p=0.03). CONCLUSION: No influence was detected of the materials on the postoperative quality of life and patient satisfaction. An overall better quality of life was reported by younger and normal-weight patients with prophylactic or nipple-sparing mastectomy without radiotherapy.

Postoperative Complications in Breast Reconstruction With Porcine Acellular Dermis and Polypropylene Meshes in Subpectoral Implant Placement.

AIM: This research compares postoperative complication rates with Strattice™, SERAGYN® BR, and TiLOOP® Bra interposition devices for subpectoral implant placement after skin or nipple sparing mastectomy. PATIENTS AND METHODS: 188 breast reconstructions in 157 patients after primary (n=96), secondary (n=71), or prophylactic (n=21) surgery were analyzed regarding major and minor complications. RESULTS: With acellular dermal matrix (ADM) Strattice™, 27.5% major and 27.5% minor complications occurred. Implant loss rates were 27.3% in primary and 30.8% in secondary reconstructions. With SERAGYN® BR, 11.1% major and 13,0% minor complications occurred. Implant losses (6.1%) occurred exclusively in primary reconstructions. With TiLOOP® Bra, 14.9% major and 9.6% minor complications occurred. Implant loss rates were 7.7% in primary and 7.1% in secondary reconstructions. CONCLUSION: ADM was associated with high complication rates in primary and secondary reconstructions. Low complication rates were seen with mesh interposition devices in primary, secondary, and prophylactic reconstructions.

A Retrospective Head-to-head Comparison Between TiLoop Bra/TiMesh® and Seragyn® in 320 Cases of Reconstructive Breast Surgery.

BACKGROUND/AIM: Clinical data concerning synthetic meshes in comparison to acellular dermal matrices (ADMs) in breast reconstruction are limited. Also, direct comparisons between titanium-coated polypropylene mesh and partially absorbable polypropylene mesh have not yet been reported. MATERIALS AND METHODS: This analysis represents a retrospective, single-surgeon, multi-center study of 320 cases using either TiLoop Bra/TiMesh® (n=192) or Seragyn® (n=128) in breast reconstruction. Results were compared with ADM-based reconstructions (Epiflex® and SurgiMend®). RESULTS: Major complication rates (i.e. revision surgery) occurred in 3.9% (Seragyn®) and 8.3% (TiLoop Bra/TiMesh®) of all cases. Minor complications occurred in 18% (Seragyn®) and 8.9% (TiLoop Bra/TiMesh®). Subgroup analysis showed red breast syndrome to occur more often in the Seragyn group (3.9% Seragyn® vs. 0.5% TiLoop Bra/TiMesh®, p<0.05). CONCLUSION: TiLoop Bra/TiMesh® and Seragyn® do not differ significantly in complication rates. There was no difference in performance when compared to ADMs.

A retrospective comparative analysis of risk factors and outcomes in direct-to-implant and two-stages prepectoral breast reconstruction: BMI and radiotherapy as new selection criteria of patients.

Recently prepectoral breast reconstruction (PBR) has showed acceptable outcomes in the short-term. There are few evidence on long-term results and variables which could influence surgical safety. So far, no specific guidelines or indications have been developed for prepectoral technique and heterogeneous inclusion criteria had been used in previous reports. This study revises a series of 397 patients. We conducted a retrospective comparative analysis of risk factors and outcomes between patients undergoing direct to-implant (DTI) and patients undergoing two-stages expander-assisted (TSE) PBR. Univariate binary logistic regression was performed to investigate the association between the incidence of postoperative and aesthetic complications and several variables. 521 breasts were included in the analysis, with an average follow-up of 38 months. 210 patients underwent DTI and 187 TSE PBR. No statistical differences were found between the two populations in term of the characteristics of patients, surgeries and outcomes. Binary logistic regression found no significant association in the TSE group. In the DTI group, a significant association was found between surgical complications and BMI and adjuvant radiotherapy. The association remained significant only for BMI, when investigated with the onset of aesthetic complications. Lower BMI and adjuvant radiotherapy are significantly associated to a higher risk of developing a surgical complication in DTI PBR. Patients at lowest BMI with DTI are prone to develop an aesthetic complication. According to this analysis, we suggest to carefully choose candidates for PBR and propose new selection criteria for subcutaneous techniques.

Subcutaneous expanders and synthetic mesh for breast reconstruction: Long-term and patient-reported BREAST-Q outcomes of a single-center prospective study.

Recently, prepectoral breast reconstruction is experiencing a revival. Despite the growing body of early reports about subcutaneous breast reconstruction, literature lacks in long-term results and studies focusing on patient-reported outcomes and health-related quality of life. Between January 2012 and December 2016, patients undergoing mastectomy were enrolled at our institution. We selected patients diagnosed with breast cancer or genetic predisposition to breast cancer, undergoing conservative mastectomy, either nipple-sparing or skin-sparing mastectomy, and willing for prepectoral tissue expander reconstruction assisted by a synthetic mesh. Exclusion criteria were body mass index greater than 35 kg/m2 and pregnancy. BREAST-Q questionnaire was administered prior to surgery and after 1 year. Capsular contracture was evaluated using Baker scale. Oncological, surgical, and esthetic outcomes along with the changes in BREAST-Q score were analyzed over time. One hundred eighty-seven patients were enrolled, with an average age of 55.5 years. One hundred thirty-seven unilateral mastectomy and 50 bilateral mastectomy procedures were performed, accounting for a total of 237 operated breasts. The average follow-up period after the second stage was 36.5 months. Postoperative complications that require a second operation occurred in 16 cases (6.7%) (4 wound dehiscence, 2 skin-nipple necrosis, 7 infections, and 3 seroma cases). A locoregional recurrence occurred in 3 cases (1.9%) and a systemic recurrence occurred in 2 cases (1.3%). Patients scored high level of satisfaction with outcome. Overall satisfaction with breasts, psychosocial well-being, and sexual well-being was all significantly increased after the surgery (p < 0.05). Two-stage expander reconstruction technique provides the preservation of the pectoralis major muscle with an acceptable rate of complications. We confirm satisfactory patient-reported and esthetic results, with high patient comfort.

Nipple-sparing bilateral prophylactic mastectomy and immediate reconstruction with TiLoop® Bra mesh in BRCA1/2 mutation carriers: A prospective study of long-term and patient reported outcomes using the BREAST-Q.

BACKGROUND: Although demand for prophylactic mastectomy is increasing over time among women at a high risk for breast cancer, there is a paucity of studies on long term patient-reported outcomes after this procedure. METHODS: Between January 2011 and January 2015, 46 patients documented BRCA1/2 mutation carriers, eligible for prophylactic nipple-sparing mastectomy (NSM) and immediate breast prosthetic reconstruction were registered at our Institution. Patients underwent NSM and subcutaneous reconstruction with implant covered by a titanium-coated polypropylene mesh (TiLoop®). The BREAST-Q questionnaire was given to patients prior to surgery and at 1 and 2 years follow-up points. Capsular contracture was evaluated by Baker scale. Surgical outcomes along with the changes in BREAST-Q score were analyzed over time. RESULTS: Complications were reported in only one case and after two years the capsular contracture rates were acceptable (grade I: 65,2%; grade II: 32,6%; grade III 2,2%). At one year and two year follow-ups patients reported high rates in the measures of overall satisfaction with breasts (72,5 and 73,7 respectively), psychosocial well-being (78,4 and 78,6), sexual well-being (58,8 and 59,4), physical well-being (77,6 and 80,6) and overall satisfaction with outcome (75,7 and 79,7). A statistically significant increase in all BREAST-domains from the preoperative to the postoperative period was reported at one and two years follow-ups (p < 0,05). CONCLUSION: Following bilateral prophylactic NSM and immediate subcutaneous reconstruction with TiLoop®, patients demonstrated high levels of satisfaction and quality of life as measured by BREAST-Q. 2-years outcomes confirmed high patient comfort with increased scores from the preoperative baseline level.

Risk-reducing, conservative mastectomy-analysis of surgical outcome and quality of life in 272 implant-based reconstructions using TiLoop(®) Bra versus autologous corial flaps.

BACKGROUND: Different approaches have evolved for conservative mastectomies, mostly according to surgeon's preference. Patients' perspective was not always in the primary focus. BRCA status has drawn much attention and therapeutic as well as prophylactic mastectomies are rising. However, knowledge on quality of life (QoL) thereafter is limited. We investigated the surgical and patient reported outcome of conservative mastectomies with implants and TiLoop(®) Bra vs. corial flaps. METHODS: Conservative mastectomies were analyzed from a prospectively maintained database in a unicentric study of consecutive 272 reconstructions from 2000-2014. We used four validated QoL questionnaires: FACT-G, EORTC C-30, EORTC B-23 and Breast Cancer Treatment Outcome Scale (BCTOS). The use of TiLoop(®) Bra, a titanized polypropylene mesh, for lower breast pole coverage was compared to autologous corial flaps. RESULTS: A total of 217 patients with 272 conservative mastectomies (55 bilateral) were included. Median follow-up was 3.5 years (range, 0-14 years). Skin-sparing mastectomy (SSM) was performed in 131 patients and subcutaneous mastectomy (SCM) in 86 patients. Invasive breast-cancer was the indication for surgery in 106 patients, non-invasive breast cancer (DCIS) in 80 patients, prophylactic indication (BRCA1/2-mutation) in 30 patients and contralateral alignment in 1 patient. TiLoop(®) Bra was used in 78 and corial flap in 79 patients. Response to questionnaires was 70%. TiLoop(®) Bra improved aesthetic results (P=0.049) and prevented implant dislocation (P=0.009). All patients expressed their adherence to the decision for surgery. Patients with SCM expressed their satisfaction even to a higher extent than those with SSM, particulary with regard to symmetry (P=0.018) and scars (P=0.037). CONCLUSIONS: QoL after conservative mastectomies is demonstrated as excellent in several validated QoL-instruments. Double-plane technique for coverage of the implant yields good results with autologous corial flaps and Tiloop(®) Bra, favouring the latter in terms of aesthetics and prevention of implant dislocation.

Skin-Areola, Nipple Sparing, and Subcutaneous Mastectomy and Immediate Implant-Based Breast Reconstruction Using a Titanium-Coated Polypropylene Mesh.

Skin sparing and nipple areola complex sparing subcutaneous mastectomies are both oncologically safe surgical procedures. Although autologuous breast reconstruction has been considered as a standard means of surgical approach, excellent cosmetic results have been obtained by implant based breast reconstruction. In this report, we present the result of titanium coated polypropylene mesh (Tiloop Bra; Pfm Medical, Cologne, Germany), an ultimate support material utilized in the reconstruction of a patient with breast cancer.

Patient-Reported Outcomes in Implant-Based Breast Reconstruction Alone or in Combination with a Titanium-Coated Polypropylene Mesh - A Detailed Analysis of the BREAST-Q and Overview of the Literature.

Background: Complication rates and surgical outcomes are well reported for implant-based breast reconstruction (IBBR) using supportive materials for the inferior pole of the breast. Patient-reported outcomes (PRO) are underrepresented. The aim of this study was to compare PRO in IBBR using implants alone or in combination with a synthetic mesh. Methods and Methods: PRO was measured in patients undergoing IBBR alone or in combination with a titanium-covered polypropylene mesh (TiLOOP® Bra). In this non-randomized observational trial PRO was retrospectively assessed using the validated self-reporting BREAST-Q. The raw responses of all questions applied in each domain and transformed BREAST-Q data using the Q-Score are presented. Results: Of 90 eligible women, 42 received IBBR alone and 48 received IBBR in combination with mesh. No differences in complication rates were observed. The return rate was 67.7 % and was comparable between the groups (p = 0.117). PRO revealed no differences regarding satisfaction with breast shape (p = 0.079), outcome (p = 0.604), nipple sensitivity (p = 0.502), preoperative information (p = 0.195), office staff (p = 0.462), psychosocial well-being (p = 0.370), sexual well-being (p = 0.508) and physical well-being (p = 0.654). Significant differences were noted regarding satisfaction with the surgeon (p = 0.013) and medical staff (p = 0.035) as well as the response behavior of certain questions of the sub-domains, thus helping to further stratify PRO with regards to aesthetic outcome. However, no differences were observed in the main BREAST-Q results. Conclusion: Use of the TiLOOP® Bra in IBBR results in comparable BREAST-Q scores compared with IBBR alone. Evaluating the BREAST-Q sub-domains helps to stratify PRO more profoundly and assists in interpreting the overall results and specific research questions.

Application status of commonly used patches in breast reconstruction / 中国肿瘤临床

Breast reconstruction is an essential part in the comprehensive management of breast cancer. The clinical application of patches (e.g., acellular dermal matrix, ADM) is the most impactful innovation in implant breast reconstruction in recent years. The wide application of patches in implant breast reconstruction promotes the development of immediate prosthetic reconstruction, im-proves the aesthetic outcomes of reconstructed breasts, and avoids additional donor tissue damage caused by autologous flap breast reconstruction. At present, patches used in breast reconstruction are mainly ADMs, bovine pericardial patches, and TiLOOP, which are widely used because of their good histocompatibility and tissue defect repair ability. This article reviews the applications and research statuses of these patches.